Monday, July 15th, 2013
Nanotechnology is a booming industry. The manipulation of tiny, nanoscale particles has created breakthroughs in medicine, agriculture, electronics and virtually every other sector of commerce. By 2015, the world market for products that contain nanomaterials is expected to reach $2.6 trillion, according to the U.S. Government Accountability Office (GAO), Congress’s watchdog.
It’s growth that any industry would envy. But reports from the Environmental Protection Agency (EPA), GAO, academic researchers and manufacturers reveal the downside of such rapid development: Nobody really knows if these wonder products are safe. Thirteen years after Congress created the National Nanotechnology Initiative (NNI) to advance the field, questions abound as to what impact these small particles might have on the environment, as well as on the human body.
“It’s been challenging to get really good data on what the hazards of the nanomaterials are,” said industry consultant John DiLoreto. “For some substances, we know very little.” An executive with Procter & Gamble, interviewed at an EPA workshop on nanomaterials, put it another way: “The cat’s out of the bag.”
Interviews with researchers and regulators show that answers to these health and safety questions are not likely to come anytime soon. That’s a troubling prospect for many public health officials, who question the wisdom of allowing businesses to market these nanomaterials without first requiring proof that they do no harm. But nanomaterials are now either produced or used by many, if not most, of the nation’s largest businesses to make some of their products. These companies have used their lobbying clout not only to beat back efforts to regulate nanomaterials, but also to counter attempts by government agencies to find out what, exactly, is being used. Federal efforts to get a handle on the safety and health risks posed by nanoparticles have also been hampered by disagreement over how to test them; which ones to test first; and a federal mandate that places developing a robust nanotechnology industry over ensuring public safety.
“It’s complex,” said Andrew Maynard, director of the University of Michigan Risk Science Center and an expert in emerging technologies. “We’ve done an awful lot of research over the last few years. We’ve made some breakthroughs, but we are still struggling to get our hands around what makes nanomaterials harmful and how to make them safe.”
"We are still struggling to get our hands around what makes nanomaterials harmful and how to make them safe."
University of Michigan
Risk Science Center
The difficulty is exacerbated by the sheer number of nano-sized chemicals. There are thousands of types, each with myriad applications. Nano-silver, for example, can be embedded in children’s toys, textiles, crops and appliances to kill harmful microorganisms, or it can be used as a disinfectant spray. Nanoscale titanium dioxide is used as a pigment in sunscreens, and in white powdered-sugar frostings, as well as for water treatment and other uses. The strength and heat-conducting qualities of carbon nanotubes make them valuable when rolled up as tiny pipes and used in computer screens or as bone replacement and for strengthening materials from tennis rackets to airplanes.
J. Clarence Davies, who helped create the EPA and wrote the Toxic Substances Control Act of 1976, has long sounded the alarm on nanotechnology. “The gap between the problems that exist and the problems that government actually can identify is growing,” Davies said. “On nano, the rate of innovation is extraordinary, at both the basic science level and the applied incorporation in products level. Industry is saying ‘don’t’ regulate us,” and Congress is anti-regulatory."
The risk from nanotechnology has become a sensitive topic. In 2011, the EPA’s inspector general drafted a report entitled, “EPA Cannot Effectively Assess or Manage Nanomaterial Risk.” Records show that after a high-ranking EPA official objected to the wording, the watchdog agency changed the name of the report. It was released in late December 2011 as the less alarming, “EPA Needs to Manage Nanomaterial Risks More Effectively.” The substance of the report was much the same. The report noted, “We found that EPA does not currently have sufficient information or processes to effectively manage the human health and environmental risks of nanomaterials. EPA has the statutory authority to regulate nanomaterials but currently lacks the environmental and human health exposure and toxicological data to do so effectively.”
The study also reported that the EPA’s efforts are hampered by reliance on industry-submitted data and said that its voluntary program, in which businesses were asked to provide data on their nanomaterials, was a flop. Few businesses cooperated. The IG also recommended that the EPA promote public awareness about nanomaterials. “The agency as a whole should provide for a more transparent overall message [about nanomaterials], and it could better use its website to do so.” The watchdogs wrote that the EPA should “keep American people well informed on “nanomaterials“ benefits, and risks, exposures and EPA’s regulatory approach.”
The GAO also said that the National Nanotechnology Initiative had overestimated the amount of government funding for environmental, health and safety research, and it recommended changes to internal audits to create a more accurate picture. The NNI’s website says that federal research dedicated to nano-related environmental, health and safety grew substantially from $35 million in fiscal year 2005 to an estimated $117 million requested for fiscal year 2011. “This includes research investments for the first time at the Food and Drug Administration and the Consumer Product Safety Commission. The cumulative [environmental, health and safety] investment since 2005 totals more than $480 million,” the website notes.
Todd Kuiken, a nanotechnology expert and senior program associate with the Woodrow Wilson Center, advocates better focus and more research dollars on the environmental implications on nanomaterials. “It took too long to focus on environmental issues,” he said. “The stuff is already out there, and you are playing catch-up.”
The EPA is examining nanomaterials on a case-by-case basis, but with at least a couple of thousand nanomaterials in use, progress has been slow. At a mid-June “stakeholders” meeting held by NNI, Kuiken was one of a number of critics who showed their frustration with the pace of progress on environmental health and safety. “The problem with the NNI is that they put out the really good strategic plans, but at the end of the day, it’s up to the individual agencies to actually implement those strategies,” he said. “It was purposely set up that way, but particularly in the funding climate that we are in now, without some strong leadership to force the agencies to fund that specific research, it doesn’t seem to be getting the attention it deserves.”
To the industry, that is just fine. Consider the U.S. Chamber of Commerce, which spent $136 million lobbying last year in total. On its website’s nanotechnology page, the organization makes its position clear: hands off the industry. “Some luddites are urging the United States to proceed under the precautionary principle, advocating inaction until any possible risks associated with nanotechnology have been identified and quantified,” the group writes. “Such a course would not only be unwise, but it would almost certainly cost the United States the opportunity to define the regulatory landscape in this field. Instead, as a nation, we should continue to develop commercial applications for nanotechnology while simultaneously pursuing efforts to standardize risk assessment protocols.”
The businesses and trade groups lobbying against proposed action on nanotechnology by the EPA, the Food and Drug Administration and other federal agencies include the American Chemistry Council and its nanotechnology business panel. Among the panel’s members are Procter & Gamble, BASF Corp., Dow Chemical Co., DuPont, Lockheed Martin Corp. and 3M, all of which use nanomaterial in making at least some of their products or processes. Other key lobbying groups are the NanoBusiness Commercialization Association and the Nanotechnology Industries Association. Nanotechnology practices have sprung up in law and lobby firms, among them Steptoe & Johnson LLP, Foley & Lardner LLP and Bergeson & Campbell PC. The combined amount of money spent on lobbying by these firms last year was more than $200 million, and their campaign contributions to federal candidates during the 2011-2012 election cycle exceeded $120 million.
One of the best-known scientist-lobbyists, Rosalind Volpe, made a name for herself defending another industry with a public health and environmental public relations problem: lead. Volpe runs the Silver Nanotechnology Working Group and remains a consultant to the International Lead Zinc Research Organization.
“She knows how to lobby for difficult chemicals,” said Jaydee Hanson, a senior policy analyst at the Center for Food Safety, which studies the impact of nanotechnology on food. “She works for five little companies, but they’ve managed to hold up regulations over at the OMB,” a reference to the White House Office of Management and Budget.
The heart of the argument made by the nano-silver industry, as well as by much of the nanotechnology business, is that the chemicals have the same properties in their nanoscale size as they do in their bulk size. “We believe that silver and nano-silver are the same,” said Volpe, who also works for the Bergeson & Campbell law firm. She added, “The companies don’t want to be nano-silver.”
But what makes nanoparticles so revolutionary is the fact that they often do behave differently than their bulk versions. Unlike their bulk versions, they may penetrate the skin, be inhaled into the lungs, cross the blood-brain barrier. There is evidence that nano-silver particles in clothing can flake off during washing, for example, or that babies can chew them off towels. Other substances such as nanoscale platinum catalyst particles are now ubiquitous in the environment, mainly in roadside dust, though scientists also suspect they have gotten into the waterways.
“They are probably pretty safe,” says Maynard. “But these particles are designed to make chemical reactions go faster. People are going to be breathing them in, and getting them into the skin. Will they enable chemical reactions inside the body to go faster? Platinum is one of those chemicals you probably don’t want too much of inside your body.” Maynard is also concerned about CMP powders. Silicon Valley uses them to polish semiconductor chips, and they may seep into the environment.
In June 2011, the EPA proposed a measure to force businesses to notify the agency if they were using nanoscale chemicals in pesticide products and, if they were, to submit health, safety and environmental data.
Lynn Bergeson, name partner in Bergeson & Campbell, which has a large nanotechnology practice, said she expects the proposal to die. “That rule has not been formally withdrawn, but it’s probably no longer considered viable due to the number of adverse comments,” she said.
The EPA has been able to push through some regulations. On June 26, 2013, the EPA issued significant new use rules for 14 nanomaterials including several carbon nanotubes and fullerenes, requiring companies making the nanomaterials to prevent exposure to workers and prevent environmental releases. EPA also identified what safety data the agency is seeking. The EPA also proposed significant new use rules for 15 additional ones on Feb. 25, 2013. EPA is reviewing the public comments for the proposed rules.
Beyond the politics, there are scientific roadblocks over the safety of products that contain nanomaterial, said Davies, a former EPA assistant administrator. Ordinary toxicity testing procedures used for what are called “bulk-scale chemicals” don’t work well on nanomaterials. For example, Davies said, a typical assumption when researchers assess the safety of a chemical is that the more there is of it, the more dangerous it may be. That logic doesn’t necessarily follow, however, in nanotechnology, where the more there is of something, the more it clumps together, and the more resistant it may be to penetrating the lungs or disbursing into the environment. “It’s an advantage to have more rather than less,” Davies said.
In the absence of data, several states are trying to take action. In December 2010, California’s Department of Toxic Substances Control launched a data call-in for six nanomaterials. The goal was to identify information gaps on the chemicals. The Environmental Council of the States, an association of staffers of state environmental departments, recently issued a report noting concerns about nano-scale mercury and suggesting that the government consider restricting it.
Vincent Caprio, executive director of the NanoBusiness Commercialization Association, expressed dismay that the EPA has had trouble keeping up with the field — which is surprising considering his organization’s members have not been supplying the data.
“I do research for our government and for EPA,” he said. “The EPA uses me to do work. They will have me, confidentially, do research on say, the use of the science of nanotechnology, as it relates to water technology products. ... Our government will call me and say, ‘Vince, we need research on, could you tell us 20 private sector companies and what their utilization of nano is and what the products are? They don’t know that. It blows your mind.”
Caprio and Bergeson both contend that nanotechnology poses no safety hazards. “We all tend to circle back to there’s no evidence, no reason, no empirical basis to believe there is any threat posed,” Bergeson said.
Hearing Bergeson’s comment, one scientist, who recently left the National Institute of Environmental Health Sciences, suggested that she “needs a better review of the literature. There are some materials that are benign. The dose — how much of the material you are exposed to — is very important.” Also, the scientist said, “We have no information about chronic exposure, or whether or not those materials have a delay of 10 or 15 years,” like asbestos, which caused silicosis, a chronic lung disease, 20 years after exposure.
But Kuiken, Maynard and others say regulators don’t have all the evidence they need to make an informed decisions because researchers haven’t looked for it.
Asked if all nanotechnology products are safe, even Caprio hedges. “You have to go product by product. We want all products to be safe. There could be 10 products they can’t guarantee, but 190 they can.”
She is also a Lab Fellow with the Edmond J. Safra Center for Ethics at Harvard University and a prize-winning investigative reporter. She is a former lecturer at the University of California, Berkeley Graduate School of Journalism, specializing in the intersection of politics, money and public health. Her work has appeared in The Washington Post, msnbc.com. Discover magazine, The Nation, The New Republic, Salon and U.S. News & World Report.